Ketamine-assisted integrative treatment for Veterans with chronic low back pain and depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The project first enrolls a small open-label group of five Veterans to pilot ketamine infusions followed by a brief narrative behavioral intervention and collect participant feedback and safety data. After initial refinement, the study proceeds to a single-blind, two-arm pilot randomized trial with 44 Veterans (22 per arm) comparing the combined ketamine-plus-behavioral approach to minimally enhanced usual care. Primary aims are feasibility, acceptability, and safety, with semi-structured exit interviews used to refine procedures. Outcome data from the pilot will be used to calculate sample size for a larger randomized trial targeting pain interference and depressive symptoms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Veterans with self-report of moderate to severe, high impact chronic low back pain (defined as 4/10 in severity via NRS, present 3 months on most days) and associated pain interference (defined as T-score 60 on the PROMIS Pain Interference measure), and current significant depressive symptoms (defined as a score 11 on the Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR).
* Medically stable (no hospitalizations in the past month lasting 3 days).
* No changes in pain or depression medication regimen in 4 weeks.
* No planned surgery, injections, hospitalizations, or other new interventions for back pain (except for physical therapy or exercise) or depression during the next four months (study duration).
* Participants must have an adult who can drive them home after the ketamine treatments.

Exclusion Criteria:

* Inability to speak English due to the narrative intervention being conducted in English.
* Inability or unwillingness to provide written informed consent (e.g. current delirium).
* Current psychotic symptoms, or history of schizophrenia, schizoaffective disorder, and other psychotic disorder.
* Currently participating in another clinical trial for pain or depression.
* Current uncontrolled hypertension (defined as systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg).
* Known elevated intracranial pressure, cerebral arterial aneurysm, or elevated intraocular pressure.
* History of cirrhosis or unstable cardiac condition (e.g., decompensated congestive heart failure).
* Any of the following lab values \>2x upper limit of normal: alanine transaminase (ALT), aspartate transferase (AST), direct bilirubin, alkaline phosphatase, creatinine; thyroid stimulating hormone (TSH) \<2x lower limit of normal or \>2x upper limit of normal.
* Positive urine pregnancy test or lack of birth control method in Veterans of childbearing potential.
* Known hypersensitivity to any excipient in the ketamine injection formulation.
* Previously experienced serious adverse effects with ketamine.
* On day of ketamine infusions, a urine drug screen positive for non-prescribed substances(s) (except cannabis) will exclude a participant from receiving ketamine
* Current or previous abuse of ketamine.

Where it's running

• VA Ann Arbor Healthcare System, Ann Arbor, MI
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Victoria D Powell, MD — VA Ann Arbor Healthcare System, Ann Arbor, MI
• Study coordinator: Victoria D Powell, MD
• Email: Victoria.Powell2@va.gov
• Phone: (734) 845-3072

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effects of psilocybin on chronic low back pain and depression

  This study is testing if a single high dose of psilocybin can help people with chronic low back pain and depression feel better.

  Recruiting Phase 1 Johns Hopkins University · Baltimore, Maryland · NCT06355414

• Ultrasound-Guided Thoracolumbar Fascia Injection for Chronic Low Back Pain in Type 2 Diabetes

  This trial tests whether an ultrasound-guided injection into the thoracolumbar fascia, added to standard care, helps reduce chronic low back pain in adults with type 2 diabetes.

  Recruiting Kanuni Sultan Suleyman Training and Research Hospital · Küçükçekmece, Istanbul · NCT07927530

• Smartphone-supported single-session psychotherapy for postpartum depression

  A single online therapy session plus four weeks of app-based support is being tested to see if it reduces depressive symptoms in postpartum women compared with a waitlist.

  Recruiting University of Sao Paulo · São Paulo, São Paulo · NCT07925762

• Mindful Smartphone Use: A Mindfulness-Based Program for Teens with Sleep and Mood Challenges

  This study tests Mindwire, a mindfulness-based program, to see if it helps teens with problematic phone use who also have depression or anxiety.

  Recruiting Brown University · Providence, Rhode Island · NCT07892807

• Tele-based wellbeing centres for women's mental health in Bangladesh

  A randomized trial tests whether tele-counselling for depression and anxiety in Bangladeshi women is as effective as in-person counselling.

  Recruiting at 2 sites International Centre for Diarrhoeal Disease Research, Bangladesh · Chāndpur, Matlab Dakshin and 1 other locations · NCT07890896

• Remote monitoring for adults with depression using ThIA Suivi

  This study tests whether adding the ThIA Suivi remote monitoring tool to usual psychiatric care helps adults with depression feel more improved after 3 months compared with standard care alone.

  Recruiting at 3 sites Phase 1 ThIA Santé Mentale · Bron and 2 other locations · NCT07878754

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.